Randomized Comparison of the Clinical Outcome of Single Versus Multiple Arterial Grafts: The Roma Trial (H-52899)

ROMA:WOMEN is a prospective un-blinded randomized multicenter clinical trial. Patients will be randomized to a single arterial graft (SAG) or multiple arterial grafts (MAG). All patients will receive a single internal thoracic artery (ITA) to the left anterior descending coronary artery (LAD). In the Multiple Arterial Graft group, the major vessel to the lateral wall will be grafted with a radial artery or a second ITA. The primary outcome will be a composite of death from any cause, non-procedural myocardial infarction, repeat revascularization, and hospital readmission for acute coronary syndrome or heart failure in a cohort of 2,000 women randomized 1:1 to MAG or SAG. The secondary outcome will be the impact of MAG vs SAG on generic and disease-specific Quality of Life (QOL), and physical and mental health symptoms in women undergoing CABG. This study is sponsored/funded by WEILL MEDICAL COLLEGE OF CORNELL UNIVERSITY (US).